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MAUDE Adverse Event Report

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CYBERONICS, INC. NCP PULSE GENERATOR   Back to Search Results
Model Number 100
Event Date 05/24/2000
Event Type  Death   Patient Outcome  Death;
Manufacturer Narrative

Report is incomplete because no response has been rec'd to mfr's request for add'l info from treating neurologist. H. 6. Review of mfg records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. Review of device programming history revealed that device diagnostic testing on day of implant was within normal limits, indicating proper device function at that time.

 
Event Description

Mfr periodically compares device tracking info to the social security death index for the purpose of updating device tracking data. Mfr became aware of pt death during this process and evaluated available info against current procedures. The event did not meet mdr reporting criteria per mfr's current procedures. In an effort to obtain add'l info regarding pt deaths for summary reporting request, certificate of death was requested, received and reviewed by mfr. Death certificate indicates that pt died in hosp e. R. Immediate cause of death is listed as pulseless electrical activity (for minutes duration), due to or as a consequence of severe seizure disorder (for years duration). No autopsy was performed. There is no evidence that the ncp system caused or contributed to the reported event; however, based on the reported cause of death, although it is not believed that it is likely that the vns therapy caused or contributed to the pt's death, it cannot be definitively ruled out as a factor.

 
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Brand NameNCP PULSE GENERATOR
Type of DevicePULSE GENERATOR
Baseline Brand NameNCP PULSE GENERATOR
Baseline Generic NamePULSE GENERATOR
Baseline Catalogue NumberNA
Baseline Model Number100
Baseline Device FamilyNA
Baseline Device PMA NumberP970003
Baseline Shelf Life Information Yes
Is Baseline 510(K) Number Provided? No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)18
Date First Marketed07/16/1997
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd.
ste 600
houston TX 77058
Manufacturer Contact
darlene garner, rac
100 cyberonics blvd., ste. 600
houston , TX 77058
(281) 228 -7200
Device Event Key502694
MDR Report Key513687
Event Key487387
Report Number1644487-2004-00164
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Company Representative,Other
Reporter Occupation Other
Type of Report Initial
Report Date 08/07/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/02/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date06/30/2000
Device MODEL Number100
Device LOT Number19476C
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/04/2004
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/1999
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/02/2004 Patient Sequence Number: 1
#TreatmentTreatment Date
1,MODEL 300-20 NCP BIPOLAR LEAD,
2,EXPIR DATE 9/30/2000, DATE OF MFG 9/23/1998,
3,STERILIZATION LOT NO. 16292C.
 
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